Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
Medical device recall Z-2593-2026. Published in FDA’s Enforcement Report on Jul 1, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 1, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 34 states named
- 113, 843 kits how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ABDOMINAL VASCULAR-LF DYNJ905291B DYNJ905291C ARTERIOGRAM DYNJ28082G CVICU HEART BAG DYKM2130A ENDOVASCULAR PACK DYNJ0678934J EP PACK DYNJ23456J GENERAL ENDO PACK-LF DYNJ0842873K HYBRID PACK DYNJ65925B DYNJ65925C NON VASCULAR PACK DYNJ68037 PACEMAKER DYNJ901681D PACEMAKER PACK DYNJ51853C DYNJ51853D DYNJ60606A PACER PACK DYNJ40952A RADIOLOGY VASCULAR ACCESS TRAY DYNJVB1303A SM- INTERVENTIONAL DRAPE PK-LF DYNJ0780143K VASCULAR ACCESS PACK-LF DYNJ0101291D VASCULAR DSC DYNJ69172 DYNJ69172B VASCULAR HYBRID DYNJ57543F DYNJ57543I DYNJ57543J VASCULAR PACK DYNJ61702A
113, 843 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
DYNJ905291B UDI-DI 10193489950373 Lots 21GBO405 21JBX734 21LBO216 DYNJ905291C UDI-DI 10195327062545 Lots 22BBB434 22CBT553 22CBT556 22FBE950 22GBZ363 22LBQ583 23ABE635 23CBI463 DYNJ28082G UDI-DI 10195327050559 Lots 22BBL073 22DBT712…
Every code shown here, 1,802 characters
DYNJ905291B UDI-DI 10193489950373 Lots 21GBO405 21JBX734 21LBO216 DYNJ905291C UDI-DI 10195327062545 Lots 22BBB434 22CBT553 22CBT556 22FBE950 22GBZ363 22LBQ583 23ABE635 23CBI463 DYNJ28082G UDI-DI 10195327050559 Lots 22BBL073 22DBT712 22FBU975 22IBD336 22LBH042 23BBG319 23CBW711 23EBF014 DYKM2130A UDI-DI 10195327630904 Lot 24ELA817 DYNJ0678934J UDI-DI 10195327637378 Lot 24FMI941 DYNJ23456J UDI-DI 10193489449839 Lot 21BMB927 DYNJ0842873K UDI-DI 10195327286613 Lots 22KDB463 23ADA210 23CDA339 23CDB773 23EDB190 23FDB457 23HDA476 23IDC327 23JDB182 23JDC057 24ADB081 24BDB286 24CDB934 24GDA042 24HDA590 24HDC238 DYNJ65925B UDI-DI 10193489925326 Lots 21FLA630 21GLA415 21HLA270 21JLA166 21KLA318 22CLA057 22CLA817 22DLA206 22ELA964 DYNJ65925C UDI-DI 10195327201371 Lots 23CLB075 23ELA853 23HLA442 23ILA022 DYNJ68037 UDI-DI 10193489473889 Lots 21ABT991 21HBL486 DYNJ901681D UDI-DI 10193489308099 Lot 24EMH538 DYNJ51853C UDI-DI 10193489269000 Lots 21CBB992 21DBA936 21FBE790 21HBN274 21KBA699 21KBP057 DYNJ51853D UDI-DI 10195327101336 Lots 22EBB104 22HBF054 22IBE507 22JBJ069 22KBS971 22LBT245 22NBG258 22OBI766 23ABI851 DYNJ60606A UDI-DI 10193489693386 Lot 24BBA469 DYNJ40952A UDI-DI 10193489941906 Lots 21GBR992 21JBX464 22BBS266 22CBP195 22EBS044 DYNJVB1303A UDI-DI 10193489928358 Lots 23ELB088 23FLA355 DYNJ0780143K UDI-DI 10195327477240 Lot 24AMI797 DYNJ0101291D UDI-DI 10193489381931 Lots 21CDC066 21EDB518 21GDC932 21HDC814 22BDA495 22DDB731 22DDC457 22EDB642 22GDA964 22JDA001 22JDC181 DYNJ69172 UDI-DI 10193489899603 Lots 21GMA692 21IMH791 DYNJ69172B UDI-DI 10195327487027 Lot 23KMC637 DYNJ57543F UDI-DI 10195327279028 Lot 23AMF931 DYNJ57543I UDI-DI 10195327359362 Lot 23CMD266 DYNJ57543J UDI-DI 10195327416027 Lots 23GMD945 23GMG266 DYNJ61702A UDI-DI 10193489470321 Lots 21CBN901 21FBM858 21GBE705
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.
The states and territories these words name
34 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Illinois
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- Tennessee
- Texas
- Virginia
- Wisconsin
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 27, 2026.
- FDA classified it on Jun 25, 2026.
- FDA’s Enforcement Report published it on Jul 1, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medline Industries, LP, of Northfield, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.